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Affichage des articles du septembre, 2016

Manquements sur l'intégrité des données pour ce fabricant chinois...

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Des remarques d'inspection de la US FDA mettent encore en cause les pratiques de "data and record management" pour ce fabricant chinois d'API :

1.Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards. Your quality control laboratory failed to record and maintain complete data from analyses of your (b)(4) ((b)(4)) API. For example: Prior to conducting official analyses,your quality control laboratory performed “experimental” analyses on product batches to assess whether your API met specifications, but failed to document these “experimental” tests in official laboratory records or to justify their exclusion. Our investigator found the results of 2,404 high performance liquid chromatography (HPLC) injections in a folder titled “Experimental” on instrument SZG-002-006l. Your quality unit indicated that these “experimental” injections were being co…

Des nouvelles injonctions sur la "data integrity"...

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Pour ce laboratoire indien, dans le cas des accès à des fichiers contenant des données réglementées (APR) :

4.    Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

For example, the computer in your quality unit area did not have controls to restrict access and prevent unauthorized changes to data files and folders. All employees had access to your Annual Product Review (APR) spreadsheet. The desktop computer containing the APR was not locked.
Pour ce fabricant chinois d'API, des nombreux écarts ont été notés :

1.    Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.

During the inspection, FDA investigators discovered a lack of basic laboratory controls to prevent changes to your electronically-stored data and paper records…